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Diss Factsheets
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EC number: 701-365-5 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- GLP guideline studies on similar substances justified by analog approach for RA.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no adverse effect observed
Additional information
A second one-generation study with the read across substance B, covering the sulfuric acid mono-[2-(4-amino-benzenesulfonyl)-ethyl] ester metabolite was performed.
There were no test item related effect on the general state and behavior of animals, but an increased urine excretion and water consumption was found at 750 mg/kg bw/day group from day 2 until the termination of the treatment.Polyuria and polydipsia are well-known side effects for lithium. As the content of lithium is rather high in this test substance, these effects were most likely related to the lithium salt content. As a secondary effect of the polyuria in high-dose dams, the mortality of pups was a slightly higher at this dose level. The NOEL for reproductive performance of parental animals was 750 mg/kg body weight (high dose). Due to the secondary higher mortality of high-dose pups, the NOEL for the offspring was set to 300 mg/kg body weight. Due to the fact that no lithium is contained in the test substance no adverse effects on reproductive performance of parental animals or their offspring is expected for the test substance up to the limit dose of 1000 mg/kg body weight.
Short description of key information:
Read across for toxicity to reproduction from one generation studies of two reactive vinyl sulphone dyes
Justification for selection of Effect on fertility via oral route:
Both studies to be considered
Effects on developmental toxicity
Description of key information
No effects on embryofetal development were observed at the limit dose of 1000 mg/kg bw/day.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Limit test performed according to OECD guideline 414
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a GLP compliant limit test performed according to OECD guideline 414, the test substance, dissolved in distilled water, was administered orally by stomach tube in a single daily dose of 1000 mg/kg body weight to a group of 20 pregnant female Wistar rats from the 7th - 16th day of pregnancy. On the 21st day the foetuses delivered by caesarean section were then examined morphologically for developmental disorders.There were no impairment observed ingeneral physical condition of the dams or impaired intrauterine development of conceptuses. the internal organs and the skeleton showed no indication of an embryotoxic or teratogenic effect of the compound.
On the basis of the results of this limit test, the “no observed adverse effect level” for the test item in rats following oral administration lies at 1000 mg/kg body weight with regard to maternal and embryofoetal toxicity and teratogenicity.
No teratogenic effect was observed.Maternal NOAEL: 1000 mg/kg/day; Fetal NOEL: 1000 mg/kg/day
Justification for selection of Effect on developmental toxicity: via oral route:
GLP guideline study
Justification for classification or non-classification
No adverse effects on reproduction toxicity observed - no classification necessary
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.